PMA P810031S054

Device: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S054
Product code: LZP
Decision date: 2015-08-25
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL TO UPDATE THE LABELING FOR THE HEALON5® OPHTHALMIC VISCOSURGICALDEVICE (OVD) TO REMOVE THE PHYSICIAN TRAINING PROGRAM FOR NEW USERS AND TO REVISE THE PRECAUTIONS SECTION OF THE DIRECTIONS FOR USE TO ALLOW FOR OTHER OVD REMOVAL TECHNIQUES.

Current openFDA PMA Record#

Device: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S054
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2015-08-25
Decision code: APPR
Date received: 2015-06-11
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE LABELING FOR THE HEALON5® OPHTHALMIC VISCOSURGICALDEVICE (OVD) TO REMOVE THE PHYSICIAN TRAINING PROGRAM FOR NEW USERS AND TO REVISE THE PRECAUTIONS SECTION OF THE DIRECTIONS FOR USE TO ALLOW FOR OTHER OVD REMOVAL TECHNIQUES.